Regulation 80 Amendment of regulation 71 (withdrawal of medicinal product from the market)I1

for sub-paragraph (a) substitute—

“(a)

under regulation 68 the licensing authority revokes or suspends a UK marketing authorisation or parallel import licence; or”; and

for sub-paragraph (b) substitute—

“(b)

under—

(i)

regulation 69 the licensing authority suspends the use, sale, supply or offer for sale or supply within Great Britain of a product to which a UKMA(GB) relates; or

(ii)

regulation 69 or Article 20(4) of Regulation (EC) No 726/2004 the licensing authority suspends the use, sale, supply or offer for sale or supply within Northern Ireland of a product to which a UKMA(NI) or UKMA(UK) relates.”.